Medication Adherence Improvement Support App For Engagement - Blood Pressure

NCT ID: NCT02727543

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-01-31

Brief Summary

The purpose of this study is to evaluate the impact of the Medisafe smartphone application on blood pressure control and self-reported medication adherence for patients with uncontrolled blood pressure.

Detailed Description

The Medication adherence Improvement Support App For Engagement - Blood Pressure (MEDISAFE-BP) trial is a prospective, intent-to-treat randomized control trial that will evaluate the impact of the Medisafe smartphone application on blood pressure control and self-reported medication adherence for patients with uncontrolled blood pressure.

Recruitment will be conducted by Evidation Health, which uses an online strategy to virtually announce, recruit, verify eligibility and enroll participants in clinical studies. Potential study subjects will be evaluated for inclusion and exclusion criteria, will give informed consent, complete the baseline assessment, and then be sent a Bluetooth-enabled home blood pressure cuff to verify that they have uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg but overall blood pressure ≤ 180/120 mmHg). Patients will be provided with a study overview and blood pressure measurement guide that will outline how to set up the monitor and take an accurate measurement, as well as the standard insert for how to use the home monitor and its associated smartphone application. Blood pressure readings will be electronically transmitted to Evidation Health via an Application Program Interface (API) with the blood pressure monitor manufacturer. Blood pressure will be calculated as the average of two measurements that are taken five minutes apart. Once their blood pressure readings have been confirmed as being elevated, patients will undergo randomization in a 1:1 ratio to intervention or control using simple randomization through a random number generated at the time of study enrollment.

Analyses will be performed by an intent-to-treat basis, where subjects will be analyzed in the groups they are assigned to during randomization. We will use linear regression to assess the impact of Medisafe on the study's two primary outcomes (change in systolic blood pressure and self-reported adherence) between the two study groups, three months after randomization.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

Participants randomized to this arm will not receive the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants randomized to this arm will receive the intervention, Medisafe, a smartphone application.

Group Type: EXPERIMENTAL

Medisafe

Intervention Type: OTHER

Medisafe is a smartphone application available to download for free on any iOS or Android device. Medisafe addresses non-adherence by providing alerts to patients when it is time to take their medications. Other features include the ability to allow a "Medfriend" to check in if a medication is not taken, weekly reports of medication adherence, and monitoring of biometric measurements

Interventions

Medisafe

Medisafe is a smartphone application available to download for free on any iOS or Android device. Medisafe addresses non-adherence by providing alerts to patients when it is time to take their medications. Other features include the ability to allow a "Medfriend" to check in if a medication is not taken, weekly reports of medication adherence, and monitoring of biometric measurements

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between 18 - 75 years of age
• Self-reported systolic blood pressure greater than or equal to 140 mmHg
• Self-reported use of 1-3 of the following anti-hypertensive medications (thiazide, CCB, beta-blocker, ACE-I, ARB)
• Systolic blood pressure greater than or equal to140 mmHg (+/- diastolic blood pressure greater than or equal to 90 mmHg), but blood pressure less than or equal to 180/120 mmHg confirmed by home BP-cuff

Exclusion Criteria

• Current use of a smartphone medication adherence application
• No ownership of a smartphone with iOS or Android operating system
• Currently taking more than 3 anti-hypertensive medications (thiazide, CCB, beta-blocker, ACE-I, ARB) by self report
• Currently undergoing dialysis
• Currently receiving chemotherapy or radiation
• Does not understand English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medisafe, Inc.

INDUSTRY

Sponsor Role: collaborator

Evidation Health

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Niteesh K. Choudhry, MD, PhD

Associate Professor, Harvard Medical School and Executive Director, Center for Healthcare Delivery Sciences, Department of Medicine, Brigham and Women's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niteesh K Choudhry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Healthcare Delivery Sciences, Brigham and Women's Hospital

Locations

Evidation Health

Menlo Park, California, United States

Countries

United States

References

Morawski K, Ghazinouri R, Krumme A, Lauffenburger JC, Lu Z, Durfee E, Oley L, Lee J, Mohta N, Haff N, Juusola JL, Choudhry NK. Association of a Smartphone Application With Medication Adherence and Blood Pressure Control: The MedISAFE-BP Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):802-809. doi: 10.1001/jamainternmed.2018.0447.

Reference Type: DERIVED

PMID: 29710289 (View on PubMed)

Other Identifiers

Pro00015278

Identifier Type: -

Identifier Source: org_study_id